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Unknown

VB119 for Focal Segmental Glomerulosclerosis

Phase 2

Waitlist Available

Research Sponsored by Tenet Medicines

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a history of steroid-sensitive MCD or FSGS with complete remission of proteinuria after corticosteroid use

Female subjects of non-childbearing potential must be surgically sterile or postmenopausal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 to day 337

Awards & highlights

Study Summary

This trial is testing a new drug to see if it can help people with kidney diseases who have previously responded to steroid therapy.

Who is the study for?

Adults over 18 with a kidney biopsy-proven diagnosis of primary MCD or FSGS within the last 10-20 years, who responded to steroids before and have had significant proteinuria in the past 2 years. Participants must be on a stable prednisone dose and have controlled blood pressure. Women must be non-childbearing or use contraception; men agree not to donate sperm for 4 months post-trial.Check my eligibility

What is being tested?

The trial is testing VB119's effectiveness in maintaining remission and prolonging response duration in adults with primary MCD or FSGS who previously responded to steroid therapy. It's a Phase 2 study across multiple centers, focusing on those who've seen benefits from steroids.See study design

What are the potential side effects?

Potential side effects of VB119 are not specified here but typically could include reactions at the infusion site, changes in blood pressure or kidney function, immune system responses, or other drug-specific effects that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney condition improved completely after using steroids.

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I am a woman who cannot have children because I am either surgically sterile or postmenopausal.

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I agree not to donate sperm for 125 days after my last dose of the study drug.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 to day 337

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 to day 337

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 to day 337 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events of special interest (AESIs)

Incidence of serious adverse events (SAEs)

Incidence of treatment-emergent adverse events (TEAEs)

+1 more

Secondary outcome measures

Change in UPCR

Change in eGFR

Proportion of subjects that are recurrence-free

Trial Design

1Treatment groups

Experimental Treatment

Group I: VB119Experimental Treatment1 Intervention

VB119 100 or 200mg IV doses administered 4 times

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tenet MedicinesLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

ValenzaBio, Inc.Lead Sponsor

2 Previous Clinical Trials

44 Total Patients Enrolled

ACELYRIN Inc.Lead Sponsor

8 Previous Clinical Trials

1,057 Total Patients Enrolled

Media Library

VB119 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05441826 — Phase 2

Nephrotic Syndrome Research Study Groups: VB119

Nephrotic Syndrome Clinical Trial 2023: VB119 Highlights & Side Effects. Trial Name: NCT05441826 — Phase 2

VB119 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05441826 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many areas is this experiment being conducted?

"This study is being conducted at 8 sites around the country, including Reno, Greenville, and Tampa. If you are considering participating in this research, please note that it may be convenient to select a location nearest you to minimize travel requirements."

Answered by AI

What is the VB119 drug's official government rating?

"Although there is no data yet supporting VB119's efficacy, there is some clinical evidence indicating that it is safe. For this reason, our team at Power gave it a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)

2022. "Efficacy and Safety of VB119 in Subjects With Minimal Change Disease (MCD) and Focal Segmental Glomerulosclerosis (FSGS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441826.

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